Samsung Bioepis seeks EMA approval of Remicade biosimilar SB2

13 March 2015

South Korea-based Samsung Bioepis, a joint venture between Samsung and US biotech firm Biogen Idec (Nasdaq: BIIB), says it has submitted Marketing Authorization Application for SB2, its biosimilar candidate Remicade (infliximab), market in Europe by Johnson & Johnson (NYSE: JNJ), to the European Medicines Agency.

This is the second biosimilar candidate MAA that Samsung Bioepis has submitted to the EMA, the first one being its SBB, a biosimilar of Amgen and Pfizer’s Enbrel (etanercept) ; The Pharma Letter January21). If authorized, SB2 will be marketed in Europe by Biogen Idec. The company intends to move forward with additional applications for regulatory approvals in other territories around the globe.

Clinical backing

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